FDA approval filed for plasma manufacturing facility

Shire files for FDA approval for a new plasma manufacturing facility in Georgia, to support its growing immunology franchise

Shire, a global biotechnology company, announced that it has filed its first submission to the US Food and Drug Administration for the company’s new
plasma manufacturing facility in Covington, Georgia.

The facility is expected to add approximately 30% capacity to the company’s internal network once fully operational. Commercial production is expected to begin in 2018.

The first submission is for the transfer of GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI).

The company expects to make a second submission to the FDA in 2018 for its albumin therapy, which is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.

“We are pleased to have filed the Georgia site and look forward to working with the FDA to seek approval for manufacturing in 2018. The additional capacity from this site is a key element to support the growth in our Immunology franchise,” said Matt Walker, Head of Technical Operations for Shire.

Shire has experienced significant growth in immunology, including a +21% increase in September year-to-date product sales in 2017 (on a pro-forma basis).

The Covington, Georgia site currently employs approximately 900 full-time colleagues and contract employees.

The site plans to ramp up hiring in 2018 to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse and a variety of support and facility roles.

Shire also expects to continue expansion of its plasma collection network in Georgia and throughout the US through its subsidiary, BioLife Plasma Services. BioLife collects the human plasma that will be processed into the drugs manufactured at Shire’s new Covington, Georgia facility.